Job Description
General Summary:
The Associate Director, QC Technical Services 6 Small Molecule will lead the technical services group responsible for GMP release and stability testing activities at external laboratories supporting commercial small molecule programs at Vertex. The role is responsible for the development and maintenance of relationships with the external testing sites to provide strategic and operational oversight for QC activities, drive compliance, monitor performance and support continuous improvement activities. The role also includes operational oversight of quality event management, stability execution, regulatory support, and cross-functional collaboration to ensure uninterrupted commercial supply to patients.
This position reports directly to the Senior Director of QC Operations and Stability
Key Duties and Responsibilities:
The responsibilities of this position may include, but are not limited to, the following:
- Provide strategic and operational oversight for GMP release and stability testing conducted at external laboratories in support of commercial supply.
- Oversee contract testing laboratories performing QC testing of drug substance, drug product intermediate, and drug products, ensuring alignment with timelines, quality standards, and quality agreements.
- Ensure the group maintains compliant execution of QC processes in accordance with SOPs, policies, and applicable industry guidance.
- Accountable for oversight of external data review processes, including appropriate assessment, escalation, and follow-up for OOS, OOE, OOT, and adverse performance or product trends.
- Provide leadership oversight for KPI monitoring and CTL performance management to support reliable, compliant, and efficient testing operations.
- Oversee quality event management within the function, including change controls, deviations, adverse stability trends, and CAPAs, ensuring timely resolution and appropriate escalation.
- Lead cross-functional alignment with MS&T, AS&T, Supply Management, Regulatory Affairs, Program Management, and Quality Assurance to support commercial small molecule programs.
- Provide functional accountability for QC input to regulatory submissions
- Ensure the group is prepared to support audits and inspections at CMOs and contract laboratories.
- Build and maintain strong relationships with internal stakeholders and external laboratories to support quality, compliance, and continuity of supply.
- Support development and strengthening of internal quality systems relevant to the technical services function.
- Support career development of direct reports
Knowledge and Skills:
- Demonstrated experience in biotech or pharmaceutical industry, in a analytical leadership role working with or in cGMP testing laboratories.
- Proven experience in building and growing a high-performance team
- Strong quality and compliance background in a commercial GMP environment with expertise in developing QC strategies, monitoring performance metrics, and driving continuous improvement initiatives.
- Problem solver with a hands-on approach and ability to anticipate adverse scenarios and provide contingency plans to address them
- Demonstrated technical background in analytical chemistry with small molecules
- Solid project management skills and experience managing complex projects.
- Strong verbal and written communication skills: ability to express oneself clearly and concisely, by adjusting style, language and/or terminology as appropriate for the audience.
- Strong leadership and proven ability to collaborate and build relationships is critical.
- Ability to work calmly and make sound decisions in a fast-moving environment of uncertainty and change
- Ability to travel, national and international, up to 20%
Education and Experience:
- Requires the following or the equivalent combination of education and experience: Master degree and 8+ years, or Bachelor's and 10+ years in pharmaceutical/biopharmaceutical industry with 6 years of increasing management responsibility, or the equivalent combination of education and experience
- Expertise in QC principles, concepts, industry practices, and standards.
- Experience in method development, validation, and transfer of non-compendial and compendial analytical methods for small molecule using various techniques such as LC/GC chromatography, dissolution, Karl Fischer, FTIR, and XRPD
- Deep knowledge in regulatory requirements and guidelines (ICH, CFR, FDA) with respect to small molecule manufacturing and release/stability testing.
- Audit/inspection interaction experience with health authorities
- Demonstrated ability to work independently and effectively to timelines in a virtual environment (i.e., internal partners, external CROs, CMOs, CTLs, etc.) and manage QC deliverables effectively.
- Excellent written and verbal communication skills.
Pay Range:
$158,800 - $238,200
Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation:
Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status:
In this Hybrid-Eligible role, you can choose to be designated as:
1.Hybrid: work remotely up to two days per week; or select
2.On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex9s Policy on Flex @ Vertex Program and may be changed at any time.
#LI-Hybrid
